BioWorld International Correspondent

WASHINGTON - Stem cell therapy stands no chance of commercial success until private investors are confident that the correct legal, ethical and regulatory environment is in place in the U.S. That despite the blandishments of countries like the UK, Singapore and Australia, where governments are vying to attract and foster stem cell research.

"The reality is that the costs of commercialization can only be met by private capital," Simon Best, CEO of Ardana Bioscience Ltd. in Edinburgh, UK, told BIO 2003 delegates last week. Large amounts of private money will be required to take stem cells through to commercialization and until a roadmap on how to address the regulatory issues is worked out in the U.S., capital investment will be held back worldwide.

Currently, the environment is most supportive in the UK, Singapore and Australia. "But if we are going to bring in private money, we have to sort out the way forward in the U.S.," Best said.

Investors are deterred by the "science fiction limbo" that embryonic stem cell research has fallen into. "In the present climate all downside risks and speculative objections are legitimate," Best said.

In addition, there are powerful forces in Europe and the U.S. that would like to stop embryonic stem cell research. "The European Union has a perverse left and right coalition of anti-technologists on the left and pro-life on the right, trying to ban this research."

In addition, Best noted, regulation in the EU is "weighed down in risk." Regulation is front-end loaded to force researchers in laboratories to look at issues that are relevant only much further down the road.

The U.S., on the other hand, has better-established regulations for traditional cell therapies and there are as yet no signs of political attempts to block the field of embryonic stem cell research by regulations, he said.

Speaking at a separate session, Tom Okarma, president and CEO of Geron Corp., of Menlo Park, Calif., told delegates the politicization of embryonic stem cells was affecting innovation and the ability to do research. "For a publicly traded biotechnology company this has been a disaster, " he said, adding, "Investors in the company are confused about what to do."

Geron's UK partner, the Roslin Institute, was awarded a license to carry out research on embryonic stem cells last month. However, Okarma told BioWorld International he was disappointed by the 18 months it took to get the license, saying, "The to-ing and fro-ing was ridiculous."

He added that governments such as the UK that "purport" to want to attract stem cell technology to their country are all underestimating how expensive it will be to take stem cell research through to commercialization. "It takes big money to move things forward. We need real big-dollar assistance."

Best, who was formerly CEO of Geron's UK subsidiary, said that all the embryonic stem cell scare stories will be seen as legitimate until there is proof of principle. "The critical landmark needed is clear clinical proof of concept in humans," he said. "This will change the name of the game, firming up the benefit side, and reducing the scope for scare-mongering." He predicted this first proof would emerge in spinal cord injury.